The generation of pulsed electric fields for tissue therapeutics has moved from the laboratory to clinical applications over the past two decades, while the effects of brief pulses of high voltages and large electric fields on tissue have been investigated for the past forty years or more. Application of brief high DC voltages to tissue may generate locally high electric fields typically in the range of hundreds of volts per centimeter that disrupt cell membranes by generating pores in the cell membrane. While the precise mechanism of this electrically-driven pore generation or electroporation continues to be studied, it is thought that the application of relatively brief and large electric fields generates instabilities in the lipid bilayers in cell membranes, causing the occurrence of a distribution of local gaps or pores in the cell membrane. This electroporation may be irreversible if the applied electric field at the membrane is larger than a threshold value such that the pores do not close and remain open, thereby permitting exchange of biomolecular material across the membrane leading to necrosis and/or apoptosis (cell death) without damage to the tissue scaffolding and structural matrix. Subsequently, the surrounding tissue may heal naturally.
In the context of gastric reflux and esophageal disease, the condition of Barrett's esophagus can generate inflammation of the esophageal mucosal lining that, in many cases, may represent a pre-cancerous stage that could develop later into a tumor. Early intervention and treatment of this condition is often warranted. Current techniques to treat this condition involve the use of an RF (Radio Frequency) balloon or cryo-balloon for ablation of the mucosal lining.
These existing techniques involving thermal ablation (heating or cooling) can cause discomfort and the therapy delivery process can take tens of minutes, while at the same time the treatment is not always effective as there may remain localized regions of tissue that have not been treated. There is a need for alternative treatment approaches that are rapid, cause minimal discomfort and are highly effective.
Given that appropriate pulsed DC voltages may drive irreversible electroporation in tissue under the right circumstances, there is an opportunity to address the unmet need for flexible, atraumatic devices that effectively deliver high pulsed DC voltage electroporation ablation therapy selectively to esophageal tissue in the esophagus while minimizing damage to healthy tissue. This need is addressed in the present disclosure.